WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number G34505 |
Device Problems
Difficult to Advance (2920); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Occupation: lab manager.Pma/510(k): k171712.Investigation is still in progress.
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Event Description
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Description of event according to initial reporter: upon filter placement, the sheath itself was put up the first time successfully and the dilator was then taken out.It was unable to be reinserted (wouldn't advance).After filter was placed, he went to hand-inject the sheath and observed a hole in the sheath.Had to switch to a short sheath.After taking it out, they observed the hole.An unknown event/other device punctured the sheath.Physician believes it was possibly user error.Not a notably tortuous anatomy so that is not believed to be a contributing factor.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.
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Manufacturer Narrative
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Manufacturer ref# (b)(4).Summary of investigational findings: sheath and dilator were placed and the dilator was removed and could not be re-inserted.Hand-injection confirmed a hole in the sheath.Reportedly attempts were made to place the filter from femoral approach, but only the jugular introducer was returned with the long introducer dilator and the blue introducer sheath.The jugular introducer had kinked 260mm and 333-336mm from the distal tip.The introducer dilator had kinked 28mm from the distal tip.And as to the introducer sheath it was twisted 351-366mm from the distal tip, kinks were noted 321mm and 564mm from same, and the reported hole was confirmed in another kink 283mm from the tip.Based on these findings the exact reason for the difficulties encountered cannot be determined, unless the hole in the sheath was caused by a filter leg.If caused by a leg, the jugular introducer with the filter was the one ¿re-inserted¿ in the sheath after removal of the dilator.Under normal conditions the sheath is strong enough to accomplish the procedure, but the sheath may kink if advanced through tortuous anatomy and the filter legs may be prone to exceed the sheath wall if advanced through a kinked sheath.However, this is only speculation based on the information provided.There are adequate controls in place to ensure that this device was manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before final release, there is evidence that the dhr was fully executed.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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